1. Field of the Invention
The present invention relates generally to devices, systems, and methods for percutaneous sealing of puncture sites in body lumens or tissue tracts. More specifically, the present invention relates to self-tensioning vascular occlusion devices, systems, and methods for its use for hemostasis of vascular puncture sites.
Percutaneous access of blood vessels in the human body is routinely performed for diagnostics or interventional procedures such as coronary and peripheral angiography, angioplasty, atherectomies, placement of vascular stents, coronary retroperfusion and retroinfusion, cerebral angiograms, treatment of strokes, cerebral aneurysms, and the like. Patients undergoing these procedures are often treated with anti-coagulants such as heparin, thrombolytics, and the like, which make the closure and hemostasis process of the puncture site in the vessel wall at the completion of such interventional procedures more difficult to achieve.
Various devices have been introduced to provide hemostasis, however none have been entirely successful. Some devices utilize collagen or other biological plugs to seal the puncture site. Alternatively, sutures and/or staples have also been applied to close the puncture site. External foreign objects such as plugs, sutures, or staples however may cause tissue reaction, inflammation, and/or infection as they all “leave something behind” to achieve hemostasis.
There is also another class of devices that use the body's own natural mechanism to achieve hemostasis wherein no foreign objects are left behind. Such devices typically provide hemostasis by sealing the puncture site from the inside of the vessel wall wherein the device is left in place in the vessel lumen until hemostasis is reached and thereafter removed. These devices generally comprises two separate and distinct components, namely a catheter and an external tensioning element. The external tensioning element is typically connected to the catheter shaft and rests on an exterior surface of the skin after the catheter is positioned in the vessel. It provides tension to the catheter at the puncture site as well as anchors the applied tension so that a tip of the deployed catheter is maintained against the vessel wall at the puncture site. The external tensioning element is kept in tension for a period of time.
Although such devices have achieved relative levels of success, the external tensioning element is not always easy and convenient in its application. Further, the external tensioning element may not always preserve the integrity of the catheter system. For example, manipulation of the catheter when the external tensioner is applied or removed may cause disruption of the seal at the vessel puncture site, resulting in bleeding or hematoma formation (i.e., leaking of blood into interstitial space). Also, the external tensioner may be subject to being dislodged accidentally while in use, which may result in complications, such as resumption of bleeding.
In light of the above, it would be desirable to provide alternative devices, systems, and methods for complete hemostasis of a puncture site in a body lumen, particularly blood vessels of the human body. It would be particularly desirable if such devices, systems, and methods utilize the body's own natural healing mechanism to achieve hemostasis. It would be further desirable if such devices and systems utilize a simple construction and user interface allowing for convenient application without numerous intermediary steps. Further, such devices should be reliable, preserve the integrity of the system, and provide for appropriate tension application without the need for user intervention. At least some of the these objective will be met by the devices, systems, and methods of the present invention described hereinafter.
2. Description of the Background Art
Hemostasis devices for use in blood vessels and tracts in the body are described in co-pending U.S. patent application Ser. Nos. 10/821,633 and 10/718,504 and U.S. Pat. Nos. 6,656,207; 6,464,712; 6,056,770; 6,056,769; 5,922,009; and 5,782,860, assigned to the assignee of the present application. The following U.S. patents and Publications may be relevant to the present invention: U.S. Pat. Nos. 4,744,364; 4,852,568; 4,890,612; 5,108,421; 5,171,259; 5,258,000; 5,383,896; 5,419,765; 5,454,833; 5,626,601; 5,630,833; 5,634,936; 5,728,134; 5,836,913; 5,861,003; 5,868,778; 5,951,583; 5,957,952; 6,017,359; 6,048,358; 6,296,657; U.S. Publication Nos. 2002/0133123; 2003/0055454; and 2003/0120291.
The full disclosures of each of the above mentioned references are incorporated herein by reference.